BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Healgen Accurate Home Multi-Drug Urine Test Cup

    Reg #: 3009238284 · FEI: 3009238284 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    HEALGEN SCIENTIFIC LLC
    Registration Number
    3009238284
    FEI Number
    3009238284
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3818 Fuqua St
    City
    Houston
    State
    TX
    ZIP
    77047
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243365

    Owner / Operator

    Firm Name
    HEALGEN SCIENTIFIC LLC
    Operator Number
    10038461
    Address
    3818 Fuqua Street
    City
    Houston
    State
    TX
    Postal Code
    77047
    Country
    US

    Products

    Device Name Product Code
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Methadone, Over The Counter PTG
    Test, Amphetamine, Over The Counter NFT
    Test, Benzodiazepine, Over The Counter NFV
    Test, Propoxyphene, Over The Counter QBF
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Cannabinoid, Over The Counter NFW
    Test, Barbiturate, Over The Counter PTH
    Test, Opiates, Over The Counter NGL
    Test, Methamphetamine, Over The Counter NGG

    Proprietary Names

    Healgen Accurate Home Multi-Drug Urine Test Cup Healgen Accurate Multi-Drug Urine Drug Screen Cup

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility